The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1-20 are pending and under consideration.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 14-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yen (US 20090304804; IDS 04.04.23). The instant claims are product claims drawn to a composition comprising a therapeutically effective amount of an albumin nanoparticle suspension containing submicron albumin spheres. The limitations “for treating multiple traumas in a subject in need thereof” is an intended use of the composition and has not been accorded patentable weight. MPEP 2111.02.
Yen teaches biologic devices for hemostasis. Yen teaches compositions comprising a suspension of albumin spheres smaller than 1 micron in diameter (nanospheres) that remains in suspension in a medium without sedimentation during prolong storage (p. 1 [0009]-[0010], p. 6 [0059]-[0060]). In working examples 6-7, Yen teaches that the albumin spheres, after synthesis, are coated with fibrinogen (p. 14-16). In working example 13, Yen teaches a composition comprising a suspension of albumin spheres, said albumin spheres having a density not substantially different from 1 g/mL, and that said albumin spheres bind fibrinogen (p. 25-26). Therefore, Yen can be deemed to anticipate instant claims 14-20.
Regarding the instant limitations that the albumin spheres are configured to augment a function or effectiveness of stem cells or precursor cells in vivo to stimulate mobilization of the stem cells or the precursor cells toward the traumas, where the traumas are different (instant claim 1), it is known that a chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. See In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). MPEP 2112.01. Since the fibrinogen-coated albumin spheres of Yen are the same as the claimed fibrinogen-coated albumin spheres, the properties of augmenting a function of stem cells would necessarily be present in the fibrinogen-coated albumin spheres of Yen.
Regarding instant claim 18, Yen teaches the spheres are suspended in saline (at least p. 15).
Regarding instant claims 19-20, as similarly noted above for instant claim 1, it is known that a chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. See In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). MPEP 2112.01. Since the fibrinogen-coated albumin spheres of Yen are the same as the claimed fibrinogen-coated albumin spheres, the properties of being configured to increase concentrations of one or more biomarkers (instant claim 19) and ameliorate an inflammatory response (instant claim 20) would necessarily be present in the fibrinogen-coated albumin spheres of Yen.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-13 are rejected under 35 U.S.C. 103 as being unpatentable over Yen (US 20090304804; IDS 04.04.23). As noted above, Yen discloses biologic devices for hemostasis. Yen discloses compositions comprising a suspension of albumin spheres smaller than 1 micron in diameter (nanospheres) that remains in suspension in a medium without sedimentation during prolong storage (p. 1 [0009]-[0010], p. 6 [0059]-[0060]). In working examples 6-7, Yen discloses that the albumin spheres, after synthesis, can be coated with fibrinogen (p. 14-16). In working example 13, Yen discloses a composition comprising a suspension of albumin spheres, said albumin spheres having a density not substantially different from 1 g/mL, and that said albumin spheres can bind fibrinogen (p. 25-26). Yen discloses that the albumin spheres can bind or be used to capture biologically active molecules, including fibrinogen (p. 30-31). Yen also discloses that the suspension of albumin spheres can be in a composition comprising a physiologically compatible excipient for in vivo use (p. 30-31). Yen discloses that the suspension of albumin spheres can comprise stabilizers and be subjected to sterilization by heat and were still efficacious when administered to mammals (p. 26-28, working example 14) and that terminal sterilization of the albumin spheres would be expected to kill all common bacteria and viruses (p. 21 [0287]). Yen also discloses that a desolvating agent (ethanol) and a cross-linking agent (glutaraldehyde) can be added to the sphere suspensions at concentrations that do not cause clumps or aggregates and result in the formation of stable protein spheres that are smaller than 1 micron (p. 20-22, p. 22-23, p. 26-28, working example 14, p. 31 claims 38-39). Yen discloses stabilizers including dextrose, lactose, maltose, glycine (p. 27 [0383], p. 31 claim 43). Yen reasonably discloses a composition comprising fibrinogen-coated albumin spheres, a supernatant, a stabilizer, desolvating agent at a concentration sufficient to result in formation of stable protein spheres and without formation of aggregates, wherein said fibrinogen-coated albumin spheres are free of bacteria and viruses. Therefore, Yen can reasonably be deemed to disclose the claimed fibrinogen-coated albumin spheres.
Yen discloses one particular application is in the field of hemostasis, where after intravenous infusion, the device (the albumin nanospheres) may capture molecules inside the body, such as a single component or a variety of coagulation factors, which then render the combination of device plus biological molecule capable of decreasing blood loss or shortening (improving) bleeding time…These devices are expected to greatly benefit patients with insufficient platelet concentrations or diminished platelet function, or in patients with tendencies of bleeding due to other causes, including cancer, aplastic anemia, surgical patients where perioperative loss is expected to be extensive but erythrocyte or platelet transfusion services are lacking, (at least [0003]-[0004]).
It is further disclosed that the device in combination will effective molecules can take the form of targeting the device to the wound site, or enhancement of endogenous platelet function, or any number of unknown mechanisms ([0013]).
The albumin spheres mimic the function of platelets and may be regarded as “artificial platelets” (at least [0046]).
Yen discloses that thrombocytopenic animals intravenously infused with the protein device showed improved bleeding time and less blood loss from surgical wounds. It is expected that animals with normal platelet count after infusion of said protein device will also have less blood loss or bleeding tendencies when challenged ([0026]).
Yen further discloses that these devices can potentially be used for treatment in surgical patients where erythrocyte or platelet transfusion services are lacking or in battlefield conditions where transfusion services are difficult (at least [0004]). Yen discloses that patients (humans and animals) can bleed for a variety of reasons; one reason is external injury such as from trauma, or during a surgical operation (at least [0044]).
Yen discloses working examples and/or methods of administering the suspension of albumin spheres (p. 26-28, 30-31). Yen discloses administering determined doses of mg of spheres per kg weight of the subject, i.e. a low dose 3 mg/kg, medium dose 10 mg/kg, a highest dose of 30 mg/kg, etc. (see at least working examples 8-12). It is also expected that the albumin spheres will improve the hemostatic condition of patients when given as a prophylactic treatment for patients who are not yet thrombocytopenic, nor thrombocytopathic, but are expected to need platelet transfusion (p. 5 [0052]) and/or erythrocyte transfusion ([0004]). Yen discloses that the albumin spheres are an ideal substitute for an artificial platelet product (at least [0052]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to arrive at the claimed method of treating multiple traumas in a subject in need thereof, comprising administering a therapeutically effective amount of an albumin nanoparticle suspension containing submicron albumin spheres to the subject suffering from multiple types of traumas, wherein the therapeutically effective amount of albumin spheres are at a dose that increases survival rate and reduces morbidity rate of the subject, wherein the albumin spheres are bound with fibrinogen molecules in vitro or in vivo, and thereby are configured to augment a function of stem cells or precursor cells in vivo to stimulate mobilization of the stem cells or precursor cells toward the traumas in the subject, wherein the multiple types of traumas are different, in view of the teachings of Yen (instant claims 1-13). The motivation to do so is given by the prior art. Yen discloses that compositions comprising fibrinogen-coated albumin spheres are hemostatic devices that can be administered as substitutes for platelet products for treating wounds in patients in need thereof, including battlefield conditions, which include bleeding from trauma, open wounds, surgical wounds, etc. Therefore, one of ordinary skill in the art would have reasonable motivation to administer the compositions comprising fibrinogen-coated albumin spheres of Yen in a method for treating multiple different types of traumas in a subject in need thereof. One of ordinary skill would have a reasonable expectation of success that the compositions comprising fibrinogen-coated albumin spheres of Yen will stimulate healing of multiple different types of trauma because it is disclosed that the fibrinogen-coated albumin spheres can be administered as substitutes for platelet products for treating wounds in various conditions, including battlefield conditions, which include bleeding from trauma, open wounds, surgical wounds, etc. (Yen).
Regarding the instant limitation that the albumin spheres are configured to augment a function or effectiveness of stem cells or precursor cells in vivo to stimulate mobilization of the stem cells or the precursor cells toward the traumas, where the traumas are different (instant claims 1, 4, 9-13), it is submitted that these are properties and/or actions of the administered fibrinogen-coated albumin spheres. Since the fibrinogen-coated albumin spheres of Yen appear to be the same as the claimed fibrinogen-coated albumin spheres and Yen discloses administering the fibrinogen-coated albumin spheres to patient populations encompassed by the instant claims, it is submitted that the properties of instant claim 1 would be naturally present and/or naturally occur from the fibrinogen-coated albumin spheres of Yen when administered to treat a patient suffering from multiple types of traumas. Mere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention. MPEP 2145.
Regarding instant claim 2, Yen discloses that patients (humans and animals) can bleed for a variety of reasons; one reason is external injury such as from trauma, or during a surgical operation (at least [0044]) and that the compositions comprising fibrinogen-coated albumin spheres are administered to treat patients in need of a platelet product, including battlefield conditions (at least paragraphs 0004, 0052). Therefore, it would be obvious that the patients can include humans.
Regarding instant claim 3, it would have been obvious to arrive at the claimed amount of 8 mg/kg or more for intravenous administration to the patient in view of Yen. Yen discloses administering determined doses of mg of spheres per kg weight of the subject, i.e. including a low dose 3 mg/kg, medium dose 10 mg/kg, a dose of 27 mg/kg, a highest dose of 30 mg/kg, etc. (see at least working examples 8-12). “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). In this instance, it would have been obvious to arrive at the claimed dosage range of spheres per kg weight of the patient in view of Yen because Yen discloses the same fibrinogen-coated albumin spheres as claimed for treating patient populations encompassed by the instant claims, i.e. patients having wounds or traumas and in need of a platelet product.
Regarding instant claim 6, Yen discloses the spheres are suspended in saline (at least p. 15).
Regarding instant claim 7, Yen discloses that patients (humans and animals) can bleed for a variety of reasons; one reason is external injury such as from trauma, or during a surgical operation (at least [0044]) and that the compositions comprising fibrinogen-coated albumin spheres are administered to treat patients in need of a platelet product, including battlefield conditions (at least paragraphs 0004, 0052). Therefore, it would be obvious that the trauma is a surgical wound.
Regarding instant claim 8, as noted above, Yen discloses that compositions comprising fibrinogen-coated albumin spheres are hemostatic devices that can be administered as substitutes for platelet products for treating wounds in patients in need thereof, including battlefield conditions, which include bleeding from trauma, open wounds, surgical wounds, etc. (at least paragraphs 0004, 0026, 0044, 0052). Yen also discloses administering the albumin spheres to irradiated animals (at least p. 17-18). Therefore, it would be obvious that the multiple different types of trauma suffered by the subject is a surgical wound and an irradiation wound or injury.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 11260109 (‘109) in view of Yen (supra). Although the claims at issue are not identical, they are not patentably distinct from each other because both the instant claims and the ‘109 patent claims are drawn to method for treating a condition in a subject in need thereof, comprising administering to the subject a composition comprising a suspension of fibrinogen-coated albumin spheres. The ‘109 patent claims differ from the instant claims by not reciting that the condition is multiple traumas of different types. However, in view of the noted teachings of Yen above, it would have been obvious to one of ordinary skill to modify the method of the ‘109 patent claims by administering the composition comprising a suspension of fibrinogen-coated albumin spheres to a subject for healing multiple traumas of different types because Yen discloses the same fibrinogen-coated albumin spheres as recited can be administered as substitutes for platelet products for treating wounds or traumas (Yen). One of ordinary skill would have a reasonable expectation of success because it is disclosed that the fibrinogen-coated albumin spheres serve as ideal substitutes for platelet products for treating wounds in various conditions, including battlefield conditions, which include bleeding from trauma, open wounds, surgical wounds, etc. (Yen).
Regarding instant claim 2, Yen discloses that patients (humans and animals) can bleed for a variety of reasons; one reason is external injury such as from trauma, or during a surgical operation (at least [0044]) and that the compositions comprising fibrinogen-coated albumin spheres are administered to treat patients in need of a platelet product, including battlefield conditions (at least paragraphs 0004, 0052). Therefore, it would be obvious that the patients recited in the ‘109 patent claims can include humans.
Regarding instant claim 3, the ‘109 patent claim 1 also recites an intravenous dose of 16 mg/kg to 24 mg/kg. Additionally, it would have been obvious to arrive at the claimed amount of 8 mg/kg or more for intravenous administration to the patient in view of Yen. Yen discloses administering determined doses of mg of spheres per kg weight of the subject, i.e. including a low dose 3 mg/kg, medium dose 10 mg/kg, a dose of 27 mg/kg, a highest dose of 30 mg/kg, etc. (see at least working examples 8-12). “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding instant claim 6, Yen discloses the spheres are suspended in saline (at least p. 15). Therefore, it would be obvious that the albumin nanoparticle suspension containing albumin spheres of the ‘109 patent claims can be suspended in saline.
Regarding instant claim 7, the ‘109 patent claim 1 recites the condition is a radiation-induced burn. Yen discloses that patients (humans and animals) can bleed for a variety of reasons; one reason is external injury such as from trauma, or during a surgical operation (at least [0044]) and that the compositions comprising fibrinogen-coated albumin spheres are administered to treat patients in need of a platelet product, including battlefield conditions (at least paragraphs 0004, 0052). Therefore, it would be obvious to administer the compositions comprising fibrinogen-coated albumin spheres recited in the ‘109 patent claims to a multiple trauma wound, including radiation-induced burn.
Regarding instant claim 8, as noted above, the ‘109 patent claim 1 recites the condition is a radiation-induced burn. Yen discloses that compositions comprising fibrinogen-coated albumin spheres are hemostatic devices that can be administered as substitutes for platelet products for treating wounds in patients in need thereof, including battlefield conditions, which include bleeding from trauma, open wounds, surgical wounds, etc. (at least paragraphs 0004, 0026, 0044, 0052). Yen also discloses administering the albumin spheres to irradiated animals (at least p. 17-18). Therefore, it would be obvious to administer the compositions comprising fibrinogen-coated albumin spheres recited in the ‘109 patent claims to a multiple trauma wound, including a surgical wound and an irradiation wound or injury.
Additionally, any components and/or elements of the instant claims that are not expressly recited in the ‘109 patent claims are reasonably suggested and disclosed in the teachings of Yen for the reasons already noted above and it would be obvious to incorporate said components and/or elements of the instant claims into the ‘109 patent claims.
Claims 1-13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 of U.S. Patent No. 9226898 (‘898) in view of Yen (supra). Although the claims at issue are not identical, they are not patentably distinct from each other because both the instant claims and the ‘898 patent claims are drawn to method for treating a condition in a subject in need thereof, comprising administering to the subject a composition comprising a suspension of fibrinogen-coated albumin spheres. The ‘898 patent claims differ from the instant claims by not reciting that the condition is multiple traumas of different types. However, in view of the noted teachings of Yen, it would have been obvious to one of ordinary skill to modify the method of the ‘898 patent claims by administering the composition comprising a suspension of fibrinogen-coated albumin spheres to a subject for healing multiple traumas of different types because Yen discloses the same fibrinogen-coated albumin spheres as recited can be administered as substitutes for platelet products for treating wounds or traumas (Yen). One of ordinary skill would have a reasonable expectation of success because it is disclosed that the fibrinogen-coated albumin spheres serve as ideal substitutes for platelet products for treating wounds in various conditions, including battlefield conditions, which include bleeding from trauma, open wounds, surgical wounds, etc. (Yen).
Regarding instant claim 2, Yen discloses that patients (humans and animals) can bleed for a variety of reasons; one reason is external injury such as from trauma, or during a surgical operation (at least [0044]) and that the compositions comprising fibrinogen-coated albumin spheres are administered to treat patients in need of a platelet product, including battlefield conditions (at least paragraphs 0004, 0052). Therefore, it would be obvious that the patients recited in the ‘898 patent claims can include humans.
Regarding instant claim 3, it would have been obvious to arrive at the claimed amount of 8 mg/kg or more for intravenous administration to the patient in view of Yen. Yen discloses administering determined doses of mg of spheres per kg weight of the subject, i.e. including a low dose 3 mg/kg, medium dose 10 mg/kg, a dose of 27 mg/kg, a highest dose of 30 mg/kg, etc. (see at least working examples 8-12). “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). In this instance, it would have been obvious to arrive at the claimed dosage range of spheres per kg weight of the patient in view of Yen because Yen discloses the same fibrinogen-coated albumin spheres as recited in the ‘898 patent claims for treating patient populations having the same need, i.e. patients having wounds and in need of a platelet product.
Regarding instant claim 6, Yen discloses the spheres are suspended in saline (at least p. 15). Therefore, it would be obvious that the albumin nanoparticle suspension containing albumin spheres of the ‘898 patent claims can be suspended in saline.
Regarding instant claim 7, the ‘898 patent claim 1 recites the condition is an anxiolytic non-thrombocytopenic patient who is not exposed to ionizing radiations and has been in contact with irradiated patients exposed to an irreversibly damaging dose of ionizing radiation. Yen discloses that patients (humans and animals) can bleed for a variety of reasons; one reason is external injury such as from trauma, or during a surgical operation (at least [0044]) and that the compositions comprising fibrinogen-coated albumin spheres are administered to treat patients in need of a platelet product, including battlefield conditions (at least paragraphs 0004, 0052). Therefore, it would be obvious to administer the compositions comprising fibrinogen-coated albumin spheres recited in the ‘898 patent claims to a multiple trauma wound, including radiation-induced burn.
Regarding instant claim 8, as noted above, the ‘898 patent claim 1 recites the condition is an anxiolytic non-thrombocytopenic patient who is not exposed to ionizing radiations and has been in contact with irradiated patients exposed to an irreversibly damaging dose of ionizing radiation. Yen discloses that compositions comprising fibrinogen-coated albumin spheres are hemostatic devices that can be administered as substitutes for platelet products for treating wounds in patients in need thereof, including battlefield conditions, which include bleeding from trauma, open wounds, surgical wounds, etc. (at least paragraphs 0004, 0026, 0044, 0052). Yen also discloses administering the albumin spheres to irradiated animals (at least p. 17-18). Therefore, it would be obvious to administer the compositions comprising fibrinogen-coated albumin spheres recited in the ‘898 patent claims to a multiple trauma wound, including a surgical wound and an irradiation wound or injury.
Additionally, any components and/or elements of the instant claims that are not expressly recited in the ‘898 patent claims are reasonably suggested and disclosed in the teachings of Yen for the reasons already noted above and it would be obvious to incorporate said components and/or elements of the instant claims into the ‘898 patent claims.
Claims 1-13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 9351925 (‘925) in view of Yen (supra). Although the claims at issue are not identical, they are not patentably distinct from each other because both the instant claims and the ‘925 patent claims are drawn to method for treating a condition in a subject in need thereof, comprising administering to the subject a composition comprising a suspension of fibrinogen-coated albumin spheres. The ‘925 patent claims differ from the instant claims by not reciting that the condition is multiple traumas of different types. However, in view of the noted teachings of Yen above, it would have been obvious to one of ordinary skill to modify the method of the ‘925 patent claims by administering the composition comprising a suspension of fibrinogen-coated albumin spheres to a subject for healing multiple traumas of different types because Yen discloses the same fibrinogen-coated albumin spheres as recited can be administered as substitutes for platelet products for treating wounds or traumas (Yen). One of ordinary skill would have a reasonable expectation of success because it is disclosed that the fibrinogen-coated albumin spheres serve as ideal substitutes for platelet products for treating wounds in various conditions, including battlefield conditions, which include bleeding from trauma, open wounds, surgical wounds, etc. (Yen).
Regarding instant claim 2, Yen discloses that patients (humans and animals) can bleed for a variety of reasons; one reason is external injury such as from trauma, or during a surgical operation (at least [0044]) and that the compositions comprising fibrinogen-coated albumin spheres are administered to treat patients in need of a platelet product, including battlefield conditions (at least paragraphs 0004, 0052). Therefore, it would be obvious that the patients recited in the ‘925 patent claims can include humans.
Regarding instant claim 3, it would have been obvious to arrive at the claimed amount of 8 mg/kg or more for intravenous administration to the patient in view of Yen. Yen discloses administering determined doses of mg of spheres per kg weight of the subject, i.e. including a low dose 3 mg/kg, medium dose 10 mg/kg, a dose of 27 mg/kg, a highest dose of 30 mg/kg, etc. (see at least working examples 8-12). “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). In this instance, it would have been obvious to arrive at the claimed dosage range of spheres per kg weight of the patient in view of Yen because Yen discloses the same fibrinogen-coated albumin spheres as recited in the ‘925 patent claims for treating patient populations having the same need, i.e. patients having wounds and in need of a platelet product.
Regarding instant claim 6, Yen discloses the spheres are suspended in saline (at least p. 15). Therefore, it would be obvious that the albumin nanoparticle suspension containing albumin spheres of the ‘925 patent claims can be suspended in saline.
Regarding instant claim 7, the ‘925 patent claim 1 recites the condition is a patient who needs blood component transfusion. Yen discloses that patients (humans and animals) can bleed for a variety of reasons; one reason is external injury such as from trauma, or during a surgical operation (at least [0044]) and that the compositions comprising fibrinogen-coated albumin spheres are administered to treat patients in need of a platelet product, including battlefield conditions (at least paragraphs 0004, 0052). Therefore, it would be obvious to administer the compositions comprising fibrinogen-coated albumin spheres recited in the ‘925 patent claims to a multiple trauma wound, including radiation-induced burn.
Regarding instant claim 8, as noted above, the ‘925 patent claim 1 recites the condition is a patient who needs blood component transfusion. Yen discloses that compositions comprising fibrinogen-coated albumin spheres are hemostatic devices that can be administered as substitutes for platelet products for treating wounds in patients in need thereof, including battlefield conditions, which include bleeding from trauma, open wounds, surgical wounds, etc. (at least paragraphs 0004, 0026, 0044, 0052). Yen also discloses administering the albumin spheres to irradiated animals (at least p. 17-18). Therefore, it would be obvious to administer the compositions comprising fibrinogen-coated albumin spheres recited in the ‘925 patent claims to a multiple trauma wound, including a surgical wound and an irradiation wound or injury.
Additionally, any components and/or elements of the instant claims that are not expressly recited in the ‘925 patent claims are reasonably suggested and disclosed in the teachings of Yen for the reasons already noted above and it would be obvious to incorporate said components and/or elements of the instant claims into the ‘925 patent claims.
Claims 1-13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 9504641 (‘641) in view of Yen (supra). Although the claims at issue are not identical, they are not patentably distinct from each other because both the instant claims and the ‘641 patent claims are drawn to method for treating a condition in a subject in need thereof, comprising administering to the subject a composition comprising a suspension of fibrinogen-coated albumin spheres. The ‘641 patent claims differ from the instant claims by not reciting that the condition is multiple traumas of different types. However, in view of the noted teachings of Yen above, it would have been obvious to one of ordinary skill to modify the method of the ‘641 patent claims by administering the composition comprising a suspension of fibrinogen-coated albumin spheres to a subject for healing multiple traumas of different types because Yen discloses the same fibrinogen-coated albumin spheres as recited can be administered as substitutes for platelet products for treating wounds or traumas (Yen). One of ordinary skill would have a reasonable expectation of success because it is disclosed that the fibrinogen-coated albumin spheres serve as ideal substitutes for platelet products for treating wounds in various conditions, including battlefield conditions, which include bleeding from trauma, open wounds, surgical wounds, etc. (Yen).
Regarding instant claim 2, Yen discloses that patients (humans and animals) can bleed for a variety of reasons; one reason is external injury such as from trauma, or during a surgical operation (at least [0044]) and that the compositions comprising fibrinogen-coated albumin spheres are administered to treat patients in need of a platelet product, including battlefield conditions (at least paragraphs 0004, 0052). Therefore, it would be obvious that the patients recited in the ‘641 patent claims can include humans.
Regarding instant claim 3, it would have been obvious to arrive at the claimed amount of 8 mg/kg or more for intravenous administration to the patient in view of Yen. Yen discloses administering determined doses of mg of spheres per kg weight of the subject, i.e. including a low dose 3 mg/kg, medium dose 10 mg/kg, a dose of 27 mg/kg, a highest dose of 30 mg/kg, etc. (see at least working examples 8-12). “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). In this instance, it would have been obvious to arrive at the claimed dosage range of spheres per kg weight of the patient in view of Yen because Yen discloses the same fibrinogen-coated albumin spheres as recited in the ‘641 patent claims for treating patient populations having the same need, i.e. patients having wounds and in need of a platelet product.
Regarding instant claim 6, Yen discloses the spheres are suspended in saline (at least p. 15). Therefore, it would be obvious that the albumin nanoparticle suspension containing albumin spheres of the ‘641 patent claims can be suspended in saline.
Regarding instant claim 7, the ‘641 patent claim 1 recites the condition is a patient who has extravasation of blood from an intravascular compartment to an extravascular compartment. Yen discloses that patients (humans and animals) can bleed for a variety of reasons; one reason is external injury such as from trauma, or during a surgical operation (at least [0044]) and that the compositions comprising fibrinogen-coated albumin spheres are administered to treat patients in need of a platelet product, including battlefield conditions (at least paragraphs 0004, 0052). Therefore, it would be obvious to administer the compositions comprising fibrinogen-coated albumin spheres recited in the ‘641 patent claims to a multiple trauma wound, including radiation-induced burn.
Regarding instant claim 8, as noted above, the ‘641 patent claim 1 recites the condition is a patient has extravasation of blood from an intravascular compartment to an extravascular compartment. Yen discloses that compositions comprising fibrinogen-coated albumin spheres are hemostatic devices that can be administered as substitutes for platelet products for treating wounds in patients in need thereof, including battlefield conditions, which include bleeding from trauma, open wounds, surgical wounds, etc. (at least paragraphs 0004, 0026, 0044, 0052). Yen also discloses administering the albumin spheres to irradiated animals (at least p. 17-18). Therefore, it would be obvious to administer the compositions comprising fibrinogen-coated albumin spheres recited in the ‘641 patent claims to a multiple trauma wound, including a surgical wound and an irradiation wound or injury.
Additionally, any components and/or elements of the instant claims that are not expressly recited in the ‘641 patent claims are reasonably suggested and disclosed in the teachings of Yen for the reasons already noted above and it would be obvious to incorporate said components and/or elements of the instant claims into the ‘641 patent claims.
Claims 1-13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 11260110 (‘110) in view of Yen (supra). Although the claims at issue are not identical, they are not patentably distinct from each other because both the instant claims and the ‘110 patent claims are drawn to method for treating a condition in a subject in need thereof, comprising administering to the subject a composition comprising a suspension of fibrinogen-coated albumin spheres. The ‘110 patent claims differ from the instant claims by not reciting that the condition is multiple traumas of different types. However, in view of the noted teachings of Yen above, it would have been obvious to one of ordinary skill to modify the method of the ‘110 patent claims by administering the composition comprising a suspension of fibrinogen-coated albumin spheres to a subject for healing multiple traumas of different types because Yen discloses the same fibrinogen-coated albumin spheres as recited can be administered as substitutes for platelet products for treating wounds or traumas (Yen). One of ordinary skill would have a reasonable expectation of success because it is disclosed that the fibrinogen-coated albumin spheres serve as ideal substitutes for platelet products for treating wounds in various conditions, including battlefield conditions, which include bleeding from trauma, open wounds, surgical wounds, etc. (Yen).
Regarding instant claim 2, Yen discloses that patients (humans and animals) can bleed for a variety of reasons; one reason is external injury such as from trauma, or during a surgical operation (at least [0044]) and that the compositions comprising fibrinogen-coated albumin spheres are administered to treat patients in need of a platelet product, including battlefield conditions (at least paragraphs 0004, 0052). Therefore, it would be obvious that the patients recited in the ‘110 patent claims can include humans.
Regarding instant claim 3, it would have been obvious to arrive at the claimed amount of 8 mg/kg or more for intravenous administration to the patient in view of Yen. Yen discloses administering determined doses of mg of spheres per kg weight of the subject, i.e. including a low dose 3 mg/kg, medium dose 10 mg/kg, a dose of 27 mg/kg, a highest dose of 30 mg/kg, etc. (see at least working examples 8-12). “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). In this instance, it would have been obvious to arrive at the claimed dosage range of spheres per kg weight of the patient in view of Yen because Yen discloses the same fibrinogen-coated albumin spheres as recited in the ‘110 patent claims for treating patient populations having the same need, i.e. patients having wounds and in need of a platelet product.
Regarding instant claim 6, Yen discloses the spheres are suspended in saline (at least p. 15). Therefore, it would be obvious that the albumin nanoparticle suspension containing albumin spheres of the ‘110 patent claims can be suspended in saline.
Regarding instant claim 7, the ‘110 patent claim 1 recites the condition is a patient who has radiation-induced skin toxicity or skin ulcer. Yen discloses that patients (humans and animals) can bleed for a variety of reasons; one reason is external injury such as from trauma, or during a surgical operation (at least [0044]) and that the compositions comprising fibrinogen-coated albumin spheres are administered to treat patients in need of a platelet product, including battlefield conditions (at least paragraphs 0004, 0052). Therefore, it would be obvious to administer the compositions comprising fibrinogen-coated albumin spheres recited in the ‘110 patent claims to a multiple trauma wound, including radiation-induced burn.
Regarding instant claim 8, as noted above, the ‘110 patent claim 1 recites the condition is a patient who has radiation-induced skin toxicity or skin ulcer. Yen discloses that compositions comprising fibrinogen-coated albumin spheres are hemostatic devices that can be administered as substitutes for platelet products for treating wounds in patients in need thereof, including battlefield conditions, which include bleeding from trauma, open wounds, surgical wounds, etc. (at least paragraphs 0004, 0026, 0044, 0052). Yen also discloses administering the albumin spheres to irradiated animals (at least p. 17-18). Therefore, it would be obvious to administer the compositions comprising fibrinogen-coated albumin spheres recited in the ‘110 patent claims to a multiple trauma wound, including a surgical wound and an irradiation wound or injury.
Additionally, any components and/or elements of the instant claims that are not expressly recited in the ‘110 patent claims are reasonably suggested and disclosed in the teachings of Yen for the reasons already noted above and it would be obvious to incorporate said components and/or elements of the instant claims into the ‘110 patent claims.
Claims 1-13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 10603287 (‘287) in view of Yen (supra). Although the claims at issue are not identical, they are not patentably distinct from each other because both the instant claims and the ‘287 patent claims are drawn to method for treating a condition in a subject in need thereof, comprising administering to the subject a composition comprising a suspension of fibrinogen-coated albumin spheres. The ‘287 patent claims differ from the instant claims by not reciting that the condition is multiple traumas of different types. However, in view of the noted teachings of Yen above, it would have been obvious to one of ordinary skill to modify the method of the ‘287 patent claims by administering the composition comprising a suspension of fibrinogen-coated albumin spheres to a subject for healing multiple traumas of different types because Yen discloses the same fibrinogen-coated albumin spheres as recited can be administered as substitutes for platelet products for treating wounds or traumas (Yen). One of ordinary skill would have a reasonable expectation of success because it is disclosed that the fibrinogen-coated albumin spheres serve as ideal substitutes for platelet products for treating wounds in various conditions, including battlefield conditions, which include bleeding from trauma, open wounds, surgical wounds, etc. (Yen).
Regarding instant claim 2, Yen discloses that patients (humans and animals) can bleed for a variety of reasons; one reason is external injury such as from trauma, or during a surgical operation (at least [0044]) and that the compositions comprising fibrinogen-coated albumin spheres are administered to treat patients in need of a platelet product, including battlefield conditions (at least paragraphs 0004, 0052). Therefore, it would be obvious that the patients recited in the ‘287 patent claims can include humans.
Regarding instant claim 3, it would have been obvious to arrive at the claimed amount of 8 mg/kg or more for intravenous administration to the patient in view of Yen. Yen discloses administering determined doses of mg of spheres per kg weight of the subject, i.e. including a low dose 3 mg/kg, medium dose 10 mg/kg, a dose of 27 mg/kg, a highest dose of 30 mg/kg, etc. (see at least working examples 8-12). “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). In this instance, it would have been obvious to arrive at the claimed dosage range of spheres per kg weight of the patient in view of Yen because Yen discloses the same fibrinogen-coated albumin spheres as recited in the ‘287 patent claims for treating patient populations having the same need, i.e. patients having wounds and in need of a platelet product.
Regarding instant claim 6, Yen discloses the spheres are suspended in saline (at least p. 15). Therefore, it would be obvious that the albumin nanoparticle suspension containing albumin spheres of the ‘287 patent claims can be suspended in saline.
Regarding instant claim 7, the ‘287 patent claim 1 recites the condition is a non-thrombocytopenic patient before surgery to control of bleeding by the patient in association with surgery. Yen discloses that patients (humans and animals) can bleed for a variety of reasons; one reason is external injury such as from trauma, or during a surgical operation (at least [0044]) and that the compositions comprising fibrinogen-coated albumin spheres are administered to treat patients in need of a platelet product, including battlefield conditions (at least paragraphs 0004, 0052). Therefore, it would be obvious to administer the compositions comprising fibrinogen-coated albumin spheres recited in the ‘287 patent claims to a multiple trauma wound, including a surgical wound.
Regarding instant claim 8, as noted above, the ‘287 patent claim 1 recites the condition is a non-thrombocytopenic patient before surgery to control of bleeding by the patient in association with surgery. Yen discloses that compositions comprising fibrinogen-coated albumin spheres are hemostatic devices that can be administered as substitutes for platelet products for treating wounds in patients in need thereof, including battlefield conditions, which include bleeding from trauma, open wounds, surgical wounds, etc. (at least paragraphs 0004, 0026, 0044, 0052). Yen also discloses administering the albumin spheres to irradiated animals (at least p. 17-18). Therefore, it would be obvious to administer the compositions comprising fibrinogen-coated albumin spheres recited in the ‘287 patent claims to a multiple trauma wound, including a surgical wound and an irradiation wound or injury.
Additionally, any components and/or elements of the instant claims that are not expressly recited in the ‘287 patent claims are reasonably suggested and disclosed in the teachings of Yen for the reasons already noted above and it would be obvious to incorporate said components and/or elements of the instant claims into the ‘287 patent claims.
Claims 1-13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 12161697 (‘697) in view of Yen (supra). Although the claims at issue are not identical, they are not patentably distinct from each other because both the instant claims and the ‘697 patent claims are drawn to method for treating a condition in a subject in need thereof, comprising administering to the subject a composition comprising a suspension of fibrinogen-coated albumin spheres. The ‘697 patent claims differ from the instant claims by not reciting that the condition is multiple traumas of different types. However, in view of the noted teachings of Yen above, it would have been obvious to one of ordinary skill to modify the method of the ‘697 patent claims by administering the composition comprising a suspension of fibrinogen-coated albumin spheres to a subject for healing multiple traumas of different types because Yen discloses the same fibrinogen-coated albumin spheres as recited can be administered as substitutes for platelet products for treating wounds or traumas (Yen). One of ordinary skill would have a reasonable expectation of success because it is disclosed that the fibrinogen-coated albumin spheres serve as ideal substitutes for platelet products for treating wounds in various conditions, including battlefield conditions, which include bleeding from trauma, open wounds, surgical wounds, etc. (Yen).
Regarding instant claim 2, Yen discloses that patients (humans and animals) can bleed for a variety of reasons; one reason is external injury such as from trauma, or during a surgical operation (at least [0044]) and that the compositions comprising fibrinogen-coated albumin spheres are administered to treat patients in need of a platelet product, including battlefield conditions (at least paragraphs 0004, 0052). Therefore, it would be obvious that the patients recited in the ‘697 patent claims can include humans.
Regarding instant claim 3, the ‘697 patent claims 3-4 also recite an intravenous dose of 16 mg/kg or 24 mg/kg. Additionally, it would have been obvious to arrive at the claimed amount of 8 mg/kg or more for intravenous administration to the patient in view of Yen. Yen discloses administering determined doses of mg of spheres per kg weight of the subject, i.e. including a low dose 3 mg/kg, medium dose 10 mg/kg, a dose of 27 mg/kg, a highest dose of 30 mg/kg, etc. (see at least working examples 8-12). “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). In this instance, it would have been obvious to arrive at the claimed dosage range of spheres per kg weight of the patient in view of Yen because Yen discloses the same fibrinogen-coated albumin spheres as recited in the ‘697 patent claims for treating patient populations having the same need, i.e. patients having wounds and in need of a platelet product.
Regarding instant claim 6, Yen discloses the spheres are suspended in saline (at least p. 15). Therefore, it would be obvious that the albumin nanoparticle suspension containing albumin spheres of the ‘697 patent claims can be suspended in saline.
Regarding instant claim 7, the ‘697 patent claim 1 recites the condition is for maintaining bone health. Yen discloses that patients (humans and animals) can bleed for a variety of reasons; one reason is external injury such as from trauma, or during a surgical operation (at least [0044]) and that the compositions comprising fibrinogen-coated albumin spheres are administered to treat patients in need of a platelet product, including battlefield conditions (at least paragraphs 0004, 0052). Therefore, it would be obvious to administer the compositions comprising fibrinogen-coated albumin spheres recited in the ‘697 patent claims to a multiple trauma wound, including a blunt trauma.
Regarding instant claim 8, as noted above, the ‘697 patent claim 1 recites the condition is for maintaining bone health. Yen discloses that compositions comprising fibrinogen-coated albumin spheres are hemostatic devices that can be administered as substitutes for platelet products for treating wounds in patients in need thereof, including battlefield conditions, which include bleeding from trauma, open wounds, surgical wounds, etc. (at least paragraphs 0004, 0026, 0044, 0052). Yen also discloses administering the albumin spheres to irradiated animals (at least p. 17-18). Therefore, it would be obvious to administer the compositions comprising fibrinogen-coated albumin spheres recited in the ‘697 patent claims to a multiple trauma wound, including a surgical wound and an irradiation wound or injury.
Additionally, any components and/or elements of the instant claims that are not expressly recited in the ‘697 patent claims are reasonably suggested and disclosed in the teachings of Yen for the reasons already noted above and it would be obvious to incorporate said components and/or elements of the instant claims into the ‘697 patent claims.
Claims 1-13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent No. 9114127 (‘127) in view of Yen (supra). Although the claims at issue are not identical, they are not patentably distinct from each other because both the instant claims and the ‘127 patent claims are drawn to method for treating a condition in a subject in need thereof, comprising administering to the subject a composition comprising a suspension of fibrinogen-coated albumin spheres. The ‘127 patent claims differ from the instant claims by not reciting that the condition is multiple traumas of different types. However, in view of the noted teachings of Yen above, it would have been obvious to one of ordinary skill to modify the method of the ‘127 patent claims by administering the composition comprising a suspension of fibrinogen-coated albumin spheres to a subject for healing multiple traumas of different types because Yen discloses the same fibrinogen-coated albumin spheres as recited can be administered as substitutes for platelet products for treating wounds or traumas (Yen). One of ordinary skill would have a reasonable expectation of success because it is disclosed that the fibrinogen-coated albumin spheres serve as ideal substitutes for platelet products for treating wounds in various conditions, including battlefield conditions, which include bleeding from trauma, open wounds, surgical wounds, etc. (Yen).
Regarding instant claim 2, Yen discloses that patients (humans and animals) can bleed for a variety of reasons; one reason is external injury such as from trauma, or during a surgical operation (at least [0044]) and that the compositions comprising fibrinogen-coated albumin spheres are administered to treat patients in need of a platelet product, including battlefield conditions (at least paragraphs 0004, 0052). Therefore, it would be obvious that the patients recited in the ‘127 patent claims can include humans.
Regarding instant claim 3, it would have been obvious to arrive at the claimed amount of 8 mg/kg or more for intravenous administration to the patient in view of Yen. Yen discloses administering determined doses of mg of spheres per kg weight of the subject, i.e. including a low dose 3 mg/kg, medium dose 10 mg/kg, a dose of 27 mg/kg, a highest dose of 30 mg/kg, etc. (see at least working examples 8-12). “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). In this instance, it would have been obvious to arrive at the claimed dosage range of spheres per kg weight of the patient in view of Yen because Yen discloses the same fibrinogen-coated albumin spheres as recited in the ‘127 patent claims for treating patient populations having the same need, i.e. patients having wounds and in need of a platelet product.
Regarding instant claim 6, Yen discloses the spheres are suspended in saline (at least p. 15). Therefore, it would be obvious that the albumin nanoparticle suspension containing albumin spheres of the ‘127 patent claims can be suspended in saline.
Regarding instant claim 7, the ‘127 patent claim 1 recites the condition is a bleeding disorder. Yen discloses that patients (humans and animals) can bleed for a variety of reasons; one reason is external injury such as from trauma, or during a surgical operation (at least [0044]) and that the compositions comprising fibrinogen-coated albumin spheres are administered to treat patients in need of a platelet product, including battlefield conditions (at least paragraphs 0004, 0052). Therefore, it would be obvious to administer the compositions comprising fibrinogen-coated albumin spheres recited in the ‘127 patent claims to a multiple trauma wound, including a surgical wound.
Regarding instant claim 8, as noted above, the ‘127 patent claim 1 recites the condition is a bleeding disorder. Yen discloses that compositions comprising fibrinogen-coated albumin spheres are hemostatic devices that can be administered as substitutes for platelet products for treating wounds in patients in need thereof, including battlefield conditions, which include bleeding from trauma, open wounds, surgical wounds, etc. (at least paragraphs 0004, 0026, 0044, 0052). Yen also discloses administering the albumin spheres to irradiated animals (at least p. 17-18). Therefore, it would be obvious to administer the compositions comprising fibrinogen-coated albumin spheres recited in the ‘127 patent claims to a multiple trauma wound, including a surgical wound and an irradiation wound or injury.
Additionally, any components and/or elements of the instant claims that are not expressly recited in the ‘127 patent claims are reasonably suggested and disclosed in the teachings of Yen for the reasons already noted above and it would be obvious to incorporate said components and/or elements of the instant claims into the ‘127 patent claims.
Claims 14-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 6264988 (‘988) in view of Yen (supra). Although the claims at issue are not identical, they are not patentably distinct from each other because both the instant claims and the ‘988 claims are drawn to a composition comprising fibrinogen-coated albumin spheres that are materially and structurally the same.
No claim is allowed.
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/Marsha Tsay/Primary Examiner, Art Unit 1656